Restrictive opioid prescribing after surgery for prolapse and incontinence: a randomized, noninferiority trial.

BACKGROUND: Opioids are routinely prescribed for postoperative pain control after gynecologic surgery with growing evidence showing that most prescribed opioids go unused. Restrictive opioid prescribing has been implemented in other surgical specialties to combat the risk for opioid misuse and diversion. The impact of this practice in the urogynecologic patient population is unknown. OBJECTIVE: This study aimed to determine if a restrictive opioid prescription protocol is noninferior to routine opioid prescribing in terms of patient satisfaction with pain control after minor and major surgeries for prolapse and incontinence. STUDY DESIGN: This was a single-center, randomized, noninferiority trial of opioid-naïve patients who underwent minor (eg, colporrhaphy or mid-urethral sling) or major (eg, vaginal or minimally invasive abdominal prolapse repair) urogynecologic surgery. Patients were excluded if they had contraindications to all multimodal analgesia and if they scored ≥30 on the Pain Catastrophizing Scale. Subjects were randomized on the day of surgery to the standard opioid prescription protocol (wherein patients routinely received an opioid prescription upon discharge [ie, 3-10 tablets of 5 mg oxycodone]) or to the restrictive protocol (no opioid prescription unless the patient requested one). All patients received multimodal pain medications. Participants and caregivers were not blinded. Subjects were asked to record their pain medication use and pain levels for 7 days. The primary outcome was satisfaction with pain control reported at the 6-week postoperative visit. We hypothesized that patient satisfaction with the restrictive protocol would be noninferior to those randomized to the standard protocol. The noninferiority margin was 15 percentage points. Pain level scores, opioid usage, opioid prescription refills, and healthcare use were secondary outcomes assessed for superiority. RESULTS: A total of 133 patients were randomized, and 127 (64 in the standard arm and 63 in the restrictive arm) completed the primary outcome evaluation and were included in the analysis. There were no statistically significant differences between the study groups, and this remained after adjusting for the surgery type. Major urogynecologic surgery was performed in 73.6% of the study population, and minor surgery was performed in 26.4% of the population. Same-day discharge occurred for 87.6% of all subjects. Patient satisfaction was 92.2% in the standard protocol arm and 92.1% in the restrictive protocol arm (difference, -0.1%; P=.004), which met the criterion for noninferiority. No opioid usage in the first 7 days after hospital discharge was reported by 48.4% of the patients in the standard protocol arm and by 70.8% in the restrictive protocol arm (P=.009). Opioid prescription refills occurred in 8.5% of patients with no difference between the study groups (9.4% in the standard arm vs 6.7% in the restrictive arm; P=.661). No difference was seen in the rate of telephone calls and urgent visits for pain control between the study arms. CONCLUSION: Among women who underwent minor and major surgery for prolapse and incontinence, patient satisfaction rates were noninferior after restrictive opioid prescribing when compared with routine opioid prescribing.

Same-day Discharge Following Vaginal Hysterectomy and Native-tissue Apical Repair for Uterovaginal Prolapse: A Prospective Cohort Study.

INTRODUCTION AND HYPOTHESIS: The safety and feasibility of same-day discharge (SDD) has been consistently reported across the benign and gynecologic oncology literature. However, outcomes of SDD in the urogynecology population are sparse. The objectives of this study were to describe the success of SDD following vaginal hysterectomy and native-tissue colpopexy, and to compare the incidence of postoperative adverse events in patients discharged same-day versus postoperative day 1 (POD1). Further objectives were to compare pain, quality of recovery (QoR), and satisfaction between the groups. METHODS: This was a single-center, prospective cohort study of patients with planned SDD. A standardized ERAS protocol was utilized. The QoR-40 questionnaire was administered at baseline, POD2, and the 6-week postoperative visit. Pain scores were captured similarly, and a satisfaction survey was administered at 6 weeks. The primary outcome was composite adverse events defined as any postoperative adverse event and/or health care utilization, excluding telephone calls, and urinary tract infection. RESULTS: A total of 101 patients were enrolled in the study; the primary outcome was available for 99. SDD was achieved for 76 patients (77.0%); 23 patients stayed overnight (23.2%). The overall incidence of composite adverse events was 20.2% (95% CI, 13.5-29.2), and was not different between the groups (26.1% vs 18.4%, p = 0.42). Additionally, there were no differences in the QoR-40 or pain scores on POD2 and at 6 weeks. Patient satisfaction was high and similar between the groups. CONCLUSIONS: Successful SDD was achieved in 77.0% of the patients. SDD following vaginal hysterectomy and native-tissue colpopexy appears to be safe, feasible, and associated with good QoR and a high degree of patient satisfaction.

Stereotactic radiosurgery versus whole brain radiotherapy in patients with intracranial metastatic disease and small-cell lung cancer: a systematic review and meta-analysis.

BACKGROUND: Patients with small-cell lung cancer (SCLC) are at high risk for intracranial metastatic disease (IMD). Although stereotactic radiosurgery (SRS) has supplanted whole brain radiotherapy (WBRT) as first-line treatment for IMD in most solid cancers, WBRT remains first-line treatment for IMD in patients with SCLC. We aimed to evaluate the efficacy of SRS in comparison with WBRT and assess treatment outcomes following SRS. METHODS: In this systematic review and meta-analysis, we searched MEDLINE, Embase, CENTRAL, and grey literature sources for controlled trials and cohort studies published in English reporting on SRS for IMD treatment in patients with SCLC from inception to March 23, 2022. Studies were excluded that did not report on SRS for IMD secondary to SCLC. Summary data were extracted. The primary outcome was overall survival, presented as pooled hazard ratios (HR) through random-effects meta-analysis for studies comparing SRS with WBRT with or without SRS boost, and as medians for single-arm SRS studies. This study is registered with the Open Science Framework, DOI 10.17605/OSF.IO/8M4HC, and PROSPERO, CRD42021258197. FINDINGS: Of 3823 identified records, 31 were eligible for inclusion; seven were included in the meta-analysis. Overall survival following SRS was longer than following WBRT with or without SRS boost (HR 0·85; 95% CI 0·75-0·97; n=7 studies; n=18 130 patients), or WBRT alone (0·77; 0·72-0·83; n=7 studies; n=16 961 patients), but not WBRT plus SRS boost (1·17, 0·78-1·75; n=4 studies; n=1167 patients). Using single-arm studies, pooled median overall survival from SRS was 8·99 months (95% CI 7·86-10·16; n=14 studies; n=1682 patients). Between-study heterogeneity was considerable when pooled among all comparative studies (I2=71·9%). INTERPRETATION: These results suggest survival outcomes are equitable following treatment with SRS compared with WBRT in patients with SCLC and IMD. Future prospective studies should focus on tumour burden and differences in local and distant intracranial progression between WBRT-treated and SRS-treated patients with SCLC. FUNDING: None.

Racial and ethnic disparities in surgical care for endometriosis across the United States.

BACKGROUND: Despite an estimated 10% prevalence of endometriosis among reproductive-age women, surgical population-based data are limited. OBJECTIVE: We sought to investigate racial and ethnic disparities in surgical interventions and complications among patients undergoing endometriosis surgery across the United States. STUDY DESIGN: We performed a retrospective cohort study of American College of Surgeons National Surgical Quality Improvement Program data from 2010 to 2018 identifying International Classification of Diseases, Ninth/Tenth Revision codes for endometriosis We compared procedures, surgical routes (laparoscopy vs laparotomy), and 30-day postoperative complications by race and ethnicity. RESULTS: We identified 11,936 patients who underwent surgery for endometriosis (65% White, 8.2% Hispanic, 7.3% Black or African American, 6.2% Asian, 1.0% Native Hawaiian or Pacific Islander, 0.6% American Indian or Alaska Native, and 11.5% of unknown race). Perioperative complications occurred in 9.6% of cases. After adjusting for confounders, being Hispanic (adjusted odds ratio, 1.31; 95% confidence interval, 1.06-1.64), Black or African American (adjusted odds ratio, 1.71; confidence interval, 1.39-2.10), Native Hawaiian or Pacific Islander (adjusted odds ratio, 2.08; confidence interval, 1.28-3.37), or American Indian or Alaska Native (adjusted odds ratio, 2.34; confidence interval, 1.32-4.17) was associated with surgical complications. Hysterectomies among Hispanic (adjusted odds ratio, 1.68; confidence interval, 1.38-2.06), Black or African American (adjusted odds ratio, 1.77; confidence interval, 1.43-2.18), Asian (adjusted odds ratio, 1.87; confidence interval, 1.43-2.46), Native Hawaiian or Pacific Islander (adjusted odds ratio, 4.16; confidence interval, 2.14-8.10), and patients of unknown race or ethnicity (adjusted odds ratio, 2.07; confidence interval, 1.75-2.47) were more likely to be open. Being Hispanic (adjusted odds ratio, 1.64; confidence interval, 1.16-2.30) or Black or African American (adjusted odds ratio, 2.64; confidence interval, 1.95-3.58) was also associated with receipt of laparotomy for nonhysterectomy procedures. The likelihood of undergoing oophorectomy was increased for Hispanic and Black women (adjusted odds ratio, 2.57; confidence interval, 1.96-3.37 and adjusted odds ratio, 2.06; confidence interval, 1.51-2.80, respectively), especially at younger ages. CONCLUSION: Race and ethnicity were independently associated with surgical care for endometriosis, with elevated complication rates experienced by Hispanic, Black or African American, Native Hawaiian or Pacific Islander, and American Indian or Alaska Native patients.

Exploring the Point-of-Sale Among Vape Shops Across the United States: Audits Integrating a Mystery Shopper Approach.

INTRODUCTION: Vape shops represent prominent, unique retailers, subject to Food and Drug Administration (FDA) regulation in the United States. AIMS AND METHODS: This study assessed compliance of US vape shop retail marketing strategies with new regulations (eg, required age verification, prohibited free samples) and pre-implementation conditions for other regulations (eg, health warning labels on all nicotine products, required disclosures of e-liquid contents). RESULTS: 95.0% of shops displayed minimum-age signage; however, mystery shoppers were asked for age verification at 35.6% upon entry and at 23.4% upon purchase. Although 85.5% of shops had some evidence of implementing FDA health warnings, 29.1% had signage indicating prohibited health claims, 16.3% offered free e-liquid samples, 27.4% had signage with cartoon imagery, and 33.3% were within two blocks of schools. All shops sold open-system devices, 64.8% sold closed-system devices, 68.2% sold their own brand of e-liquids, 42.5% sold e-liquids containing cannabidiol, 83.2% offered price promotions of some kind, and 89.9% had signage for product and price promotions. CONCLUSIONS: Results indicated that most shops complied with some implementation of FDA health warnings and with free sampling bans and minimum-age signage. Other findings indicated concerns related to underage access, health claims, promotional strategies, and cannabidiol product offerings, which call for further FDA and state regulatory/enforcement efforts.

Association of Pelvic Organ Prolapse Quantification examination D point with uterosacral ligament suspension outcomes: the "OPTIMAL" D point.

INTRODUCTION AND HYPOTHESIS: The objective was to determine the relationship between the preoperative D-point and apical outcomes at 24 months, using the Operations and Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) dataset. METHODS: This was a secondary analysis of the OPTIMAL trial, a randomized multi-centered study comparing outcomes of sacrospinous ligament fixation and transvaginal uterosacral ligament suspension (USLS). The 2-year dataset utilized included women undergoing USLS with concomitant hysterectomy. The primary outcome was the relationship between preoperative D-point and apical outcomes at 24 months. Secondary objectives were to determine the relationship between preoperative D-point and anatomical, composite and subjective outcomes, and to determine a D-point cut-off that could be used to predict success in each of these categories. RESULTS: Of the 186 women in the USLS arm, 120 were available for analysis of anatomical failure at 24 months. A higher preoperative D-point correlated with improved apical outcome (C-point) at 24 months (r = 0.34; p value = 0.0002). Using ROC curves, a moderate association was found between the preoperative D-point and apical and anatomical success, (AUC 0.689 and 0.662). There was no relationship between preoperative D-point and composite or subjective success (AUC 0.577 and 0.458). Based on the ROC curves, a "cut-off" D-point value of -4.25 cm (sensitivity = 0.58, specificity = 0.67) was determined to be a predictor of postoperative anatomical success at 2 years. CONCLUSIONS: Preoperative D-point correlates with postoperative anatomical and apical support, but is less successful at predicting subjective outcomes. The strongest predictive D-point cut-off for anatomical and apical success at 24 months was -4.25 cm.

Enhanced Recovery and Surgical Optimization Protocol for Minimally Invasive Gynecologic Surgery: An AAGL White Paper.

This is the first Enhanced Recovery After Surgery (ERAS) guideline dedicated to standardizing and optimizing perioperative care for women undergoing minimally invasive gynecologic surgery. The guideline was rigorously formulated by an American Association of Gynecologic Laparoscopists Task Force of US and Canadian gynecologic surgeons with special interest and experience in adapting ERAS practices for patients requiring minimally invasive gynecologic surgery. It builds on the 2016 ERAS Society recommendations for perioperative care in gynecologic/oncologic surgery by serving as a more comprehensive reference for minimally invasive endoscopic and vaginal surgery for both benign and malignant gynecologic conditions. For example, the section on preoperative optimization provides more specific recommendations derived from the ambulatory surgery and anesthesia literature for the management of anemia, hyperglycemia, and obstructive sleep apnea. Recommendations pertaining to multimodal analgesia account for the recent Food and Drug Administration warnings about respiratory depression from gabapentinoids. The guideline focuses on workflows important to high-value care in minimally invasive surgery, such as same-day discharge, and tackles controversial issues in minimally invasive surgery, such as thromboprophylaxis. In these ways, the guideline supports the American Association of Gynecologic Laparoscopists and our collective mission to elevate the quality and safety of healthcare for women through excellence in clinical practice.

Vaginal and laparoscopic mesh hysteropexy for uterovaginal prolapse: a parallel cohort study.

BACKGROUND: There is growing interest in uterine conservation at the time of surgery for uterovaginal prolapse, but limited data compare different types of hysteropexy. OBJECTIVE: We sought to compare 1-year efficacy and safety of laparoscopic sacral hysteropexy and vaginal mesh hysteropexy. STUDY DESIGN: This multicenter, prospective parallel cohort study compared laparoscopic sacral hysteropexy to vaginal mesh hysteropexy at 8 institutions. We included women ages 35-80 years who desired uterine conservation, were done with childbearing, and were undergoing 1 of the above procedures for stage 2-4 symptomatic anterior/apical uterovaginal prolapse (anterior descent at or beyond the hymen [Aa or Ba ≥ 0] and apical descent at or below the midvagina [C ≥ -TVL/2]). We excluded women with cervical elongation, prior mesh prolapse repair, cervical dysplasia, chronic pelvic pain, uterine abnormalities, and abnormal bleeding. Cure was defined as no prolapse beyond the hymen and cervix above midvagina (anatomic), no vaginal bulge sensation (symptomatic), and no reoperations. Pelvic Organ Prolapse Quantification examination and validated questionnaires were collected at baseline and 12 months including the Pelvic Floor Distress Inventory Short Form, Female Sexual Function Index, and Patient Global Impression of Improvement. In all, 72 subjects/group were required to detect 94% vs 75% cure (80% power, 15% dropout). Intention-to-treat analysis was used with logistic regression adjusting for baseline differences. RESULTS: We performed 74 laparoscopic sacral hysteropexy and 76 vaginal mesh hysteropexy procedures from July 2011 through May 2014. Laparoscopic patients were younger (P < .001), had lower parity (P = .006), were more likely premenopausal (P = .008), and had more severe prolapse (P = .02). Laparoscopic procedure (174 vs 64 minutes, P < .0001) and total operating time (239 vs 112 minutes, P < .0001) were longer. There were no differences in blood loss, complications, and hospital stay. One-year outcomes for the available 83% laparoscopic and 80% vaginal hysteropexy patients revealed no differences in anatomic (77% vs 80%; adjusted odds ratio, 0.48; P = .20), symptomatic (90% vs 95%; adjusted odds ratio, 0.40; P = .22), or composite (72% vs 74%; adjusted odds ratio, 0.58; P = .27) cure. Mesh exposures occurred in 2.7% laparoscopic vs 6.6% vaginal hysteropexy (P = .44). A total of 95% of each group were very much better or much better. Pelvic floor symptom and sexual function scores improved for both groups with no difference between groups. CONCLUSION: Laparoscopic sacral hysteropexy and vaginal mesh hysteropexy had similar 1-year cure rates and high satisfaction.

Defining Cervical Elongation: A Prospective Observational Study.

OBJECTIVES: Our primary aim was to define cervical elongation (CE) using the following methods: (1) measurement of pathology specimen, (2) physician perception, (3) intraoperative estimate of anterior cervical length, and (4) office Pelvic Organ Prolapse Quantification (POP-Q) points C and D. Our secondary aim was to determine whether these definitions correlate with perioperative outcomes. METHODS: Women undergoing vaginal hysterectomy and prolapse repair were enrolled. Office POP-Q measurements were collected. Estimates of cervical length were made based on points C minus D of the POP-Q and by manual exam using the surgeon's index and middle fingers. Cervical dimensions were measured from the pathology specimen at the end of the case. CE was defined as one standard deviation (SD) above the mean for each definition. Additional intraoperative data was collected to determine the surgeon perception of cervical anatomy. RESULTS: A total of 90 patients were enrolled during the study period. Our definitions for CE were as follows: (1) 5 cm (70 without and 20 with CE), (2) physician perception (67 without and 23 with CE), (3) 3.4 cm (79 without and 11 with CE), and (4) 8.3 cm (77 without and 13 with CE). After controlling for uterine weight and the presence of fibroids, the operative time was the only outcome measure that remained elevated for patients with CE using our first definition (42.4 ± 20.1 without vs. 53.8 ± 19.2 with CE, P = 0.03). CONCLUSIONS: CE using our first definition was associated with a statistically significant increase in operative time in women undergoing hysterectomy at the time of prolapse repair.

Core Privileging and Credentialing: Hospitals' Approach to Gynecologic Surgery.

STUDY OBJECTIVE: Privileging and credentialing requirements are determined by medical staff leadership at the hospital level to ensure clinicians provide safe healthcare services. No standardized guidelines exist for gynecologic surgery. The objective of this study is to examine the variability of the criteria used to grant surgical privileges and credentials for gynecologic procedures at 5 high-volume academic and community-based US hospitals. DESIGN: We conducted a cross-sectional study (Canadian Task Force classification III). SETTING: Data was obtained from obtained from 5 geographically diverse hospital systems. INTERVENTION: We examined criteria for designating core gynecologic privileges, credentialing, and other training requirements as well as minimum and annual case numbers for initial granting and maintenance of surgical privileges. MEASUREMENTS AND MAIN RESULTS: Major inconsistencies in privileging were found across the 5 institutions. Hospitals varied widely in procedures designated as core versus those requiring advanced training. Institutions greatly contrasted in the case numbers and temporal factors used to define experience. Of particular concern was absent privileging criteria for 38.4% to 76.9% of minor procedures, 26.7% to 46.7% of endoscopic procedures, and 6.67% to 56.7% of major procedures. Initial and maintenance privileging requirements for special procedures (i.e., robotic-assisted surgery) were likewise discrepant, with minimum annual case numbers ranging from 3 to 48 across hospitals. CONCLUSION: Considerable variability exists in the criteria used by hospitals for granting and maintaining surgical privileges for gynecologic procedures. Standardization will likely require efforts at a national leadership level.

Multiple cis elements and GATA factors regulate a cuticle collagen gene in Caenorhabditis elegans.

The cuticle of the nematode Caenorhabditis elegans is a specialized extracellular matrix whose major component is collagen. Cuticle collagens are encoded by a large multigene family consisting of more than 150 members. Cuticle collagen genes are expressed in epidermis (hypodermis) and may be stage-specific or cyclically expressed. We identified cuticle collagen genes as transcriptional targets of the DBL-1 TGF-ß-related signaling pathway. These studies prompted us to investigate the cis-regulatory sequences required for transcription of one of the target genes, col-41. We generated reporter constructs that reproduce stage- and tissue-specific expression of fluorescent markers. We identify four conserved sequence elements that are required for transcription of reporters. Finally, we provide evidence that col-41 expression is controlled by a sequence element containing two GATA sites and by the epidermal GATA transcription factors ELT-1 and ELT-3.

Risk factors for endometrial cancer in black and white women: a pooled analysis from the Epidemiology of Endometrial Cancer Consortium (E2C2).

PURPOSE: Endometrial cancer (EC) is the most common gynecologic cancer in the USA. Over the last decade, the incidence rate has been increasing, with a larger increase among blacks. The aim of this study was to compare risk factors for EC in black and white women. METHODS: Data from seven cohort and four case-control studies were pooled. Unconditional logistic regression was used to estimate adjusted odds ratios (OR) and 95 % confidence intervals for each risk factor in blacks and whites separately. RESULTS: Data were pooled for 2,011 black women (516 cases and 1,495 controls) and 19,297 white women (5,693 cases and 13,604 controls). BMI ≥ 30 was associated with an approximate threefold increase in risk of EC in both black and white women (ORblack 2.93, 95 % CI 2.11, 4.07 and ORwhite 2.99, 95 % CI 2.74, 3.26). Diabetes was associated with a 30-40 % increase in risk among both groups. Increasing parity was associated with decreasing risk of EC in blacks and whites (p value = 0.02 and <0.001, respectively). Current and former smoking was associated with decreased risk of EC among all women. Both black and white women who used oral contraceptives for 10 +years were also at reduced risk of EC (OR 0.49, 95 % CI 0.27, 0.88 and OR 0.69, 95 % CI 0.58, 0.83, respectively). Previous history of hypertension was not associated with EC risk in either group. CONCLUSIONS: The major known risk factors for EC exert similar effects on black and white women. Differences in the incidence rates between the two populations may be due to differences in the prevalence of risk factors.

Virtual Compared With In-Office Postoperative Visits After Urogynecologic Surgery: A Randomized Controlled Trial.

OBJECTIVE: To compare patient satisfaction, health care resource utilization, and adverse events among patients receiving a virtual video compared with in-office postoperative visit after urogynecologic surgery. We hypothesized that virtual video visits would be noninferior to in-office visits. METHODS: This was a randomized noninferiority clinical trial of patients undergoing surgery for pelvic organ prolapse and urinary incontinence at a single academic tertiary referral center. Participants were randomized to receive either a virtual video postoperative visit or a standard in-office postoperative visit. The primary outcome was patient satisfaction measured by the validated PSQ-18 (Patient Satisfaction Questionnaire-18) (noninferiority margin 5 points) at the 6-week postoperative visit. Secondary outcomes included PSQ-18 domain scores (noninferiority margin 0.5 points) and composite health care resource utilization and adverse events after the 6-week postoperative visit up to 12 weeks after surgery (noninferiority margin 10%). A sample size of 100 participants (50 per group) would allow 80% power to assess a 5-point noninferiority margin on the total PSQ-18 with an SD of 10 and α=0.05. RESULTS: From January 2023 to September 2023, 265 patients were screened for eligibility, and 104 were randomized. A total of 100 participants (50 per arm) completed the study and were included in the analysis. The mean±SD age of all participants was 57.0±13.2 years. The mean±SD PSQ-18 total score was 75.18±8.15 in the virtual group and 75.14±8.7 in the in-office group. The mean PSQ-18 total score was 0.04 points higher (ie, greater degree of satisfaction) in the virtual group, with a 95% CI of -2.75 to 2.83, which met the criterion for noninferiority. Between-group differences for all PSQ-18 domain scores likewise met criterion for noninferiority. Composite health care resource utilization was 14.0% lower in the virtual group than in the in-office group (20.0% vs 34.0%, 95% CI, -28.0% to 1.0%). For composite adverse events, the between-group difference was 2.0% (2.0% in virtual group vs 0.0% in in-office group, 95% CI,-3.0% to 8.0%). CONCLUSION: Virtual video postoperative visits were noninferior to in-office visits with regard to patient satisfaction, health care resource utilization, and adverse events and can be offered as an alternative to in-office visits for postoperative follow-up after urogynecologic surgery. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov , NCT05641077.

Effects of Social Determinants of Health and Social Support on Surgical Outcomes Among Patients Undergoing Hysterectomy.

OBJECTIVE: To describe composite 30-day postoperative complication rates among patients undergoing hysterectomy during the coronavirus disease 2019 (COVID-19) pandemic and to determine baseline and postoperative mental health symptoms, levels of social support, and socioeconomic status and their association with hysterectomy outcomes. METHODS: This multicenter prospective cohort study at eight centers across the United States enrolled patients who underwent minimally invasive hysterectomy for benign indications during the COVID-19 pandemic. Patients completed preoperative and postoperative surveys assessing mental health (PHQ-9 [Patient Health Questionnaire]), social support (MOS-SS [Medical Outcomes Study Social Support Survey]), and socioeconomic status (Hollingshead Index [Hollingshead Four Factor Index of Socioeconomic Status]). Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection rates and 30-day composite complication rates were measured and categorized by Clavien-Dindo Grade. Bivariate associations of survey data on complications were assessed. Logistic regression analyses were used to identify independent predictors of 30-day complications and complication severity. RESULTS: Postoperative complications within 30 days occurred in 67 of 273 (24.5%) patients. Most (88.1%) complications were mild, but eight (11.9%) experienced severe complications. Only three patients (1.1%) tested positive for SARS-CoV-2 infection. There were no differences in complication rates when comparing race and ethnicity, age, or socioeconomic status. Survey responses that indicated more depression and worse support from preoperative to postoperative were seen in patients with severe complications (P=.008 and P=.09, respectively). Multivariate analysis demonstrated that an increase in support scores was protective against severe complications (P=.02). Worsening depression scores were associated with more severe complications (P=.03). CONCLUSION: This study showed a high rate of complications (24.5%) among patients who underwent hysterectomy during the COVID-19 pandemic. Lower social support and worse mental health status are associated with worse postoperative outcomes after hysterectomy.

A randomized trial comparing conventional and robotically assisted total laparoscopic hysterectomy.

OBJECTIVE: The purpose of this study was to compare operative time and intra- and postoperative complications between total laparoscopic hysterectomy and robotic-assisted total laparoscopic hysterectomy. STUDY DESIGN: This study was a blinded, prospective randomized controlled trial conducted at 2 institutions. Subjects consisted of women who planned laparoscopic hysterectomy for benign indications. Preoperative randomization to total laparoscopic hysterectomy or robotic-assisted total laparoscopic hysterectomy was stratified by surgeon and uterine size (> or ≤12 weeks). Validated questionnaires, activity assessment scales, and visual analogue scales were administered at baseline and during follow-up evaluation. RESULTS: Sixty-two women gave consent and were enrolled and randomly assigned; 53 women underwent surgery (laparoscopic, 27 women; robot-assisted, 26 women). There were no demographic differences between groups. Compared with laparoscopic hysterectomy, total case time (skin incision to skin closure) was significantly longer in the robot-assisted group (mean difference, +77 minutes; 95% confidence interval, 33-121; P < .001] as was total operating room time (entry into operating room to exit; mean difference, +72 minutes; 95% confidence interval, 14-130; P = .016). Mean docking time was 6 ± 4 minutes. There were no significant differences between groups in estimated blood loss, pre- and postoperative hematocrit change, and length of stay. There were very few complications, with no difference in individual complication types or total complications between groups. Postoperative pain and return to daily activities were no different between groups. CONCLUSION: Although laparoscopic and robotic-assisted hysterectomies are safe approaches to hysterectomy, robotic-assisted hysterectomy requires a significantly longer operative time.

Blinded assessment of operative performance after fundamentals of laparoscopic surgery in gynecology training.

STUDY OBJECTIVE: To determine the pass rate for the Fundamentals of Laparoscopic Surgery (FLS) examination among senior gynecology residents and fellows and to find whether there is an association between FLS scores and previous laparoscopic experience as well as laparoscopic intraoperative (OR) skills assessment. DESIGN: Prospective cohort study (Canadian Task Force classification II-2). SETTING: Three gynecology residency training programs. PARTICIPANTS: Third- and fourth-year gynecology residents and urogynecology fellows. INTERVENTIONS: All participants participated in the FLS curriculum, written and manual skills examination, and completed a survey reporting baseline characteristics and opinions. Fourth-year residents and fellows underwent unblinded and blinded pre- and post-FLS OR assessments. Objective OR assessments of fourth-year residents after FLS were compared with those of fourth-year resident controls who were not FLS trained. MEASUREMENTS AND MAIN RESULTS: Twenty-nine participants were included. The overall pass rate was 76%. The pass rate for third- and fourth-year residents and fellows were 62%, 85%, and 100%, respectively. A trend toward improvement in OR assessments was observed for fourth-year residents and fellows for pre-FLS curriculum compared with post-FLS testing, and FLS-trained fourth-year residents compared with fourth-year resident controls; however, this did not reach statistical significance. Self-report of laparoscopic case load experience of >20 cases was the only baseline factor significantly associated with passing the FLS examination (p = .03). CONCLUSION: The FLS pass rate for senior residents and fellows was 76%, with higher pass rates associated with increasing levels of training and laparoscopic case experience.

Fewer Children in Families Associated with Lower Odds of Early Childhood Caries: A Sample from Three Countries.

Childhood caries experience is influenced by family characteristics and oral health practices in the context of many social-commercial determinants. The aim of this study was to explore the relationship between families' number of children, oral health practices and child caries experience in a convenience sample of 1374 children aged 6 months through 6 years and their families from Ecuador, Nepal, and Vietnam. Data were collected by mother interviews and child dental exams. Multivariate logistic and Zero-Inflated-Poisson regression analyses assessed associations between number of children, oral health practices and decayed, missing or filled teeth (dmft). Families had a mean of 2.2 children (range 1-12); 72% of children had tooth decay, with mean dmft of 5.4. Adjusting for child age, sex, and urban/rural location, a greater number of children in the family was associated with significantly less likelihood of unhealthy bottle feeding practices, having a toothbrush/toothpaste and parent helping child brush, and being cavity-free; higher number of dmft, and greater likelihood of having a dental visit. Early childhood oral health promotion should include focus on oral hygiene and healthy feeding-particularly breastfeeding and healthy bottle feeding practices-as well as access to family planning services and support for childcare.

Cost-effectiveness of overactive bladder treatments from a US commercial and payer perspective.

Aim: The cost-effectiveness of treatment options (anticholinergics, ß3-adrenoceptor agonists, onabotulinumtoxinA, sacral nerve stimulation and percutaneous tibial stimulation [the latter two including new rechargeable neurostimulators]) for the management of overactive bladder (OAB) were compared with best supportive care (BSC) using a previously published Markov model. Materials & methods: Cost-effectiveness was evaluated over a 15-year time horizon, and sensitivity analyses were performed using 2- and 5-year horizons. Discontinuation rates, resource utilization, and costs were derived from published sources. Results: Using Medicare and commercial costs over a 15-year time period, onabotulinumtoxinA 100U had incremental cost-effectiveness ratios (ICERs) gained of $39,591/quality-adjusted life-year (QALY) and $42,255/QALY, respectively, versus BSC, which were the lowest ICERs of all assessed treatments. The sensitivity analyses at 2- and 5-year horizons also showed onabotulinumtoxinA to be the most cost-effective of all assessed treatments versus BSC. Conclusion: OnabotulinumtoxinA 100U is currently the most cost-effective treatment for OAB.

Interest in cosmetic vulvar surgery and perception of vulvar appearance.

OBJECTIVE: The objective of the study was to determine whether reproductive-age women are more likely to perceive their vulva as abnormal compared with older-aged women. STUDY DESIGN: Women aged 18-44 years (group 1) and 45-72 years (group 2) completed a survey on demographics, grooming patterns, vulvar perceptions, and source of information about the vulva. RESULTS: There was no difference between group 1 and group 2 in how often women looked at their vulva or their perception of having a normal vulva (91% vs 93%, P = .76). Both groups were satisfied with the appearance of their vulva (81% vs 82%, P = .71). A higher percentage in group 2 would consider cosmetic surgery if cost were not an issue versus group 1 (15% vs 8%, P = .05). CONCLUSION: A woman's age does not have an impact on her perception of a normal vulva. The majority of women perceived their vulva to be normal and were satisfied with its appearance. However, older women are more interested in cosmetic vulvar surgery.